Manufacturing Supervisor, Upstream
Genezen · Indianapolis, IN
- Level
- Supervisor
- Team
- Manufacturing
- Experience asked
- 6+ years
- Industry
- Pharma & life sciences
- Posted
- 30+ days ago
The role in 30 seconds
An engineer-level manufacturing role at Genezen (pharma & life sciences) in Indianapolis, IN. Promote a safe working environment, training, and development of the manufacturing team; plan on-time execution of batch activities; deliver quality and safe viral vector products; and continuously improve manufacturing processes.
- They ask for
- 6+ years
- Tools it names
- Root cause, FDA / GMP, EHS / safety
Read from the posting. The full description is below.
How this role compares
Against 26 other live manufacturing postings in Indiana.
- Experience asked
- More than usual (6+ vs 3+)
Similar roles usually ask 3+ years.
Skills these teams ask for most
- ✓ Team leadership 74%
- Tooling 41%
- ✓ Root cause 37%
- CNC 37%
- Machining 37%
- ✓ EHS / safety 30%
✓ = this posting asks for it too. % = share of similar postings that mention it.
Stands out: this posting asks for FDA / GMP, which few similar roles mention. If you have it, lead with it.
At a glance
Pulled from the posting text. If it's not listed here, the posting didn't say.
How to get in at this plant
Five moves over a week or two. The first one takes ten minutes.
- 1
Pick 2–3 people on the Manufacturing team at Genezen
Engineers who joined in the last year or two reply the most. Use the team search on this page to find them.
- 2
Send a short, curious note
One real question about their work. No favors yet. Each person gets a different note, written for this role.
- 3
Turn a reply into a short call
Questions worth asking about this team:
- What does a normal week look like on your team?
- Is the work mostly new product launches or sustaining existing lines?
- How much time do you spend on the floor versus at a desk?
- How did you land the job? What stood out in your interviews?
- 4
Apply with someone vouching for you
If the call went well, ask whether they’d pass your résumé to the hiring manager. Send your résumé link, apply that day, and let them know.
- 5
Bring proof to the interview
One page of before-and-after numbers from projects you led: scrap, OEE, cycle time, cost. Plant managers hire on results.
This plant: Genezen in Indianapolis
2 other open roles at this site.
- Sr. Process/Validation Engineer · Quality · Senior
- Manufacturing Technician I/II/III (Contract) · Manufacturing · Technician
Full description from GenezenAs posted on their careers site.ShowHide
Job summary
Promote a safe working environment, training, and development of the manufacturing team; plan on-time execution of batch activities; deliver quality and safe viral vector products; and continuously improve manufacturing processes.
This position is located in Indianapolis, Indiana (City of Fishers) and will report to the Director of Manufacturing.
requirements
for Drug Substance Manufacturing (Viral Vector Manufacturing preferred).
- ✓Strong technical knowledge of both adherent and suspension cell lines including cell thawing, scale-up, bioreactor inoculation, transfection, harvest, and clarification.
- ✓Preferred knowledge and experience with the use and troubleshooting of Cytiva XDR 50L, Cytiva XDR 500L, Univercells Scale-X Carbo, and Cytiva iCELLis 500 bioreactors.
- ✓Monitor and report on area performance, identifying opportunities for improvement and implementing process improvements.
- ✓Design, implement, maintain, and continuously improve vector manufacturing systems, policies, procedures, and programs that ensure compliance to company and regulatory body standards for Quality and EHS.
- ✓Identify and mitigate risks in Manufacturing operations that could negatively impact product and personnel safety.
- ✓Manage the Manufacturing Production system including but not limited to personnel development, problem solving, investigation of deviations, root cause analysis, CAPAs, Change Controls, 6S, etc.
- ✓Ensure safe working environment and compliance with OSHA, EHS, Quality, and cGMP procedures and policies within the Manufacturing department
JOB
Qualifications
- ✓Prior leadership experience in GMP manufacturing facility
- ✓Preferably work experience in a comparable position (similar type of work, similar group dynamics), preferentially in an industrial organization
- ✓Ability to adhere to company internal and regulatory (EMA, FDA) policies, processes, and procedures
- ✓Hands -on experience in writing and reviewing the documentation
- ✓Experience in (bio)-manufacturing unit operations
- ✓Good writing and oral communication skills
- ✓The work schedule may require adjustments to support production activities
Requirements
- ✓Adaptability required as work schedule may change based on business needs
- ✓Criminal background check required
- ✓Other duties as assigned
On-the-job experience
4-6 years of related work experience in a GMP environment
Essential
Show full description ↓Show less ↑
The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures.
Working at genezen
Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team.
Essential job functions
- •Provide leadership, coaching, and mentoring of Upstream manufacturing personnel.
- •Oversee and execute Vector Upstream Manufacturing activities including the scheduling of resources, material staging, equipment preparation, batch execution, cleaning/sanitization, inventory transactions, and batch record review.
- •Provide on the floor training and support for upstream manufacturing operations for clinical viral vector batches.
- •Hire, coach, and develop Manufacturing team members, including performance management and periodic reviews.
- •Strong knowledge of cGMP and GDP
Essential/Desired
BS in Biology, Microbiology, Chemistry, Virology, or any other relevant field of study
Desired
In-depth knowledge of aseptic processing, GxP, cell culture, and bioreactor operation and troubleshooting
Essential
Desired
Drug Substance experience with cell culture and upstream viral vector manufacturing
Skills / abilities
Demonstrated interpersonal skills to build relationships, act as change agent, manage conflict, and adapt to rapidly changing organizational and business needs
Essential
Ability to manage multiple priorities
Essential
Work Environment
- •Frequently required to work in a BSL 2 environment with personal protective equipment/aseptic gowning
- •Regularly required to work around large machinery and typical utilities seen in pharmaceutical facilities
- •Occasionally exposed to moving mechanical parts; high, precarious places; toxic or caustic chemicals; hazardous waste; and risk of electrical shock
- •Occasionally exposed to extremely loud noise levels
- •Spending time on the floor during activity execution (manufacturing, maintenance, construction, commissioning, and qualification) is required
Movement
- •Frequently required to stand; sit; use hands to finger, handle, or feel; reach with hands and arms
- •Occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl
Lifting
- •Frequently lift and/or move up to 25 pounds
- •Occasionally lift and/or move up to 40-50 pounds
Vision
- •Frequently utilize close vision and the ability to adjust focus
- •Corrected 20/20 vision to assist with visual inspection of Drug Products
Communication
- •Frequently required to communicate by talking, hearing, using telephone and e-mail
- •Strong communication skills to efficiently collaborate and coordinate within manufacturing and cross-functional
Genezen's cures value-based competencies
C ommitted to Science
We are committed to scientific excellence, staying current with industry developments, making